Atlas FDA

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae

FDA 510(k) clearance K260195 · decided 2026-04-23

Clearance details

K-number
K260195
Device name
Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2026-01-22
Decision date
2026-04-23
Days to decision
91 days
Clearance type
Special
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an recall (Z-2810-2026)Medtronic Perfusion Systems2026-07-27
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial recall (Z-2811-2026)Medtronic Perfusion Systems2026-07-27

PMA approvals by this applicant

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Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08